Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014768
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2001-04-10
Brief Title:
Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2002-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Compare the clinical status of pregnant vs non-pregnant women with cystic fibrosis
II Determine glucose tolerance during each trimester of pregnancy in these women
III Evaluate peripheral insulin sensitivity in these women IV Evaluate whole body protein turnover and hepatic glucose production in these women
V Determine resting energy expenditure in these women
II Determine glucose tolerance during each trimester of pregnancy in these women
III Evaluate peripheral insulin sensitivity in these women IV Evaluate whole body protein turnover and hepatic glucose production in these women
V Determine resting energy expenditure in these women
Detailed Description:
PROTOCOL OUTLINE Patients undergo a glucose tolerance test over 3 hours and a potassium body scan on day 1 Patients undergo an indirect calorimetry over 20 minutes on day 2 Patients receive stable-labeled leucine and stable-labeled glucose IV over 3 hours followed by insulin and glucose IV over 4-45 hours on day 2 using the hyperinsulinemic euglycemic clamp technique
Blood and breath samples are collected to measure glucose tolerance peripheral insulin sensitivity and whole body protein turnover Hepatic glucose production is measured by mass spectrophotometry
Patients maintain a 3-day food journal before pregnancy during each trimester and after pregnancy
Patients undergo each study during the final 2 weeks of each trimester of pregnancy and then at 6 months post-partum
Blood and breath samples are collected to measure glucose tolerance peripheral insulin sensitivity and whole body protein turnover Hepatic glucose production is measured by mass spectrophotometry
Patients maintain a 3-day food journal before pregnancy during each trimester and after pregnancy
Patients undergo each study during the final 2 weeks of each trimester of pregnancy and then at 6 months post-partum
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UUSOM-IRB-7922-00 | None | None | None |